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30/09/2022 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 33, Authorised (updated)
30/09/2022 Human medicines European public assessment report (EPAR): Ertapenem SUN, ertapenem sodium, Bacterial Infections, 15/07/2022, Generic, Authorised (updated)
30/09/2022 Human medicines European public assessment report (EPAR): Lyxumia , lixisenatide, Diabetes Mellitus, Type 2, 31/01/2013, 16, Authorised (updated)
30/09/2022 Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan , Amlodipine besilate, valsartan, Hypertension, 22/03/2016, Generic, 10, Authorised (updated)
30/09/2022 Human medicines European public assessment report (EPAR): Dimethyl fumarate Mylan, dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting, 13/05/2022, Generic, 2, Authorised (updated)
30/09/2022 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 9, Authorised (updated)
30/09/2022 Methodology Working Party
30/09/2022 3Rs Working Party
30/09/2022 Non-clinical Working Party
30/09/2022 Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (seralutinib) for the: Treatment of pulmonary arterial hypertension, 29/05/2019, Positive (updated)
30/09/2022 Referral: Pholcodine-containing medicinal products , pholcodine, Article 107i procedures, Procedure started, 30/09/2022 (updated)
30/09/2022 News and press releases: Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
30/09/2022 Other: Explanatory note on pharmacovigilance fees payable to EMA (as of 3 October 2022) (updated)
30/09/2022 Product Management Services (PMS) Sub-Groups (SG) Webinar , Online, from 09/09/2022 to 09/09/2022
30/09/2022 Orphan designation: Setmelanotide for the: Treatment of Bardet-Biedl syndrome, 21/08/2019, Positive (updated)
30/09/2022 Periodic safety update single assessment: Loratadine / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00001908/202202
30/09/2022 News and press releases: New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
30/09/2022 Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome , terlipressin, Article 31 referrals, Recommendation provided by Pharmacovigilance Risk Assessment Committee, 30/09/2022 (updated)
30/09/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
30/09/2022 Other: Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors (updated)
30/09/2022 Periodic safety update single assessment: Cromoglicic acid : List of nationally authorised medicinal products - PSUSA/00000883/202202
30/09/2022 Periodic safety update single assessment: Loratadine : List of nationally authorised medicinal products - PSUSA/00001907/202202
30/09/2022 Periodic safety update single assessment: Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202203
30/09/2022 Periodic safety update single assessment: Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202203
30/09/2022 Periodic safety update single assessment: Zanamivir (except for centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00003141/202201
30/09/2022 Human medicines European public assessment report (EPAR): Nulibry, fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors, 15/09/2022, Orphan, Additional monitoring, Authorised (updated)
30/09/2022 Orphan designation: Cyclic pyranopterin monophosphate (fosdenopterin) for the: Treatment of molybdenum-cofactor deficiency type A, 20/09/2010, Positive (updated)
30/09/2022 Human medicines European public assessment report (EPAR): Comirnaty, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection, 21/12/2020, Patient safety, Additional monitoring, Conditional approval, 30, Authorised (updated)
30/09/2022 Other: Organisation chart: Advisory functions (updated)
30/09/2022 Advisory functions (updated)
30/09/2022 Orphans: Regulatory and procedural guidance and forms (updated)
29/09/2022 Referral: Topiramate , topiramate, Article 31 referrals, Procedure started, 29/09/2022 (updated)
29/09/2022 Periodic safety update single assessment: Alverine / simeticone : List of nationally authorised medicinal products - PSUSA/00000125/202202
29/09/2022 News and press releases: EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29/09/2022 Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making , European Medicines Agency, Amsterdam, the Netherlands, from 21/09/2022 to 21/09/2022 (updated)
29/09/2022 Other: Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62 (updated)
29/09/2022 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting , European Medicines Agency, Amsterdam, the Netherlands, from 22/09/2022 to 22/09/2022 (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), irbesartan, hydrochlorothiazide, Hypertension, 18/01/2007, 33, Authorised (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Glycogen Storage Disease Type II, 28/03/2006, 20, Authorised (updated)
28/09/2022 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary sclerosing cholangitis, 14/12/2015, Positive (updated)
28/09/2022 Referral: Rubraca , rucaparib, Article 20 procedures, European Commission final decision, 21/07/2022, 21/09/2022, 28/09/2022 (updated)
28/09/2022 Orphan designation: Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene for the: Treatment of haemophilia A, 21/03/2016, Positive (updated)
28/09/2022 Orphan designation: human anti-promyostatin monoclonal antibody (apitegromab) for the: Treatment of spinal muscular atrophy, 14/12/2018, Positive (updated)
28/09/2022 Orphan designation: Combretastatin A1 diphosphate for the: Treatment of acute myeloid leukaemia, 14/12/2015, Positive (updated)
28/09/2022 Orphan designation: Recombinant adeno-associated viral vector containing the human CNGB3 gene for the: Treatment of achromatopsia caused by mutations in the CNGB3 gene, 08/02/2013, Positive (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, 9, Authorised (updated)
28/09/2022 Other: Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) (updated)
28/09/2022 Other: HMPC: overview of assessment work - priority list (updated)
28/09/2022 Direct healthcare professional communication (DHPC): Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023, Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 28/09/2022 (updated)
28/09/2022 Template or form: QRD product-information template version 10.3 - highlighted (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Vyvgart, Efgartigimod alfa, Myasthenia Gravis, 10/08/2022, Orphan, Additional monitoring, 1, Authorised (updated)
28/09/2022 Product-information templates - Human (updated)
28/09/2022 Template or form: QRD product-information template version 10.3 (updated)
28/09/2022 Template or form: QRD product-information annotated template (English) version 10.3 (updated)
28/09/2022 Template or form: QRD product-information annotated template (English) version 10.3 - highlighted (updated)
28/09/2022 Template or form: QRD Appendix V - Adverse-drug-reaction reporting details (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Imcivree, Setmelanotide, Obesity, 16/07/2021, Orphan, Additional monitoring, 4, Authorised (updated)
28/09/2022 Template or form: Specimen submission form (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 28, Authorised (updated)
28/09/2022 ACT EU multi-stakeholder meeting on decentralised clinical trials , Online, 09:30 - 13:30 Amsterdam time (CEST); European Medicines Agency, Amsterdam, the Netherlands, from 04/10/2022 to 04/10/2022 (updated)
28/09/2022 Withdrawn application: Imcivree, setmelanotide, Date of withdrawal: 22/04/2022, Post-authorisation (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Obiltoxaximab SFL, Obiltoxaximab, Anthrax, 18/11/2020, Orphan, Additional monitoring, Exceptional circumstances, 2, Authorised (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 29, Authorised (updated)
28/09/2022 Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Diabetes Mellitus, 08/02/2018, Additional monitoring, 9, Authorised (updated)
28/09/2022 List of medicines under additional monitoring (updated)
28/09/2022 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
28/09/2022 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
28/09/2022 Periodic safety update single assessment: Triamcinolone (intraocular formulations) : List of nationally authorised medicinal products - PSUSA/00010292/202103
28/09/2022 Periodic safety update single assessment: Ofloxacin (topical use) : List of nationally authorised medicinal products - PSUSA/00002204/202104
28/09/2022 Orphan designation: Ilixadencel for the: Treatment of gastrointestinal stromal tumours, 26/03/2021, Positive (updated)
28/09/2022 Regulatory and procedural guideline: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure (updated)
27/09/2022 Big data (updated)
27/09/2022 Regulatory and procedural guideline: Good practice guide for the use of the Metadata Catalogue of Real-World Data Sources
27/09/2022 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 11, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Multiple Sclerosis, 12/09/2013, Additional monitoring, 20, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Tukysa, Tucatinib, Breast Neoplasms; Neoplasm Metastasis, 11/02/2021, Additional monitoring, 2, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Trizivir, abacavir (as sulfate), lamivudine, zidovudine, HIV Infections, 27/12/2000, 42, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Hemlibra, Emicizumab, Hemophilia A, 23/02/2018, Accelerated assessment, Additional monitoring, 12, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, Orphan, Additional monitoring, Conditional approval, 21, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, Additional monitoring, 6, Authorised (updated)
27/09/2022 Human medicines European public assessment report (EPAR): Zalviso, sufentanil, Pain, Postoperative, 18/09/2015, 7, Withdrawn (updated)
27/09/2022 Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities , European Medicines Agency, Amsterdam, The Netherlands, from 17/10/2022 to 20/10/2022 (updated)
27/09/2022 Veterinary Medicinal Products Regulation (updated)
27/09/2022 Minutes: Minutes of the CHMP meeting 18-21 July 2022
27/09/2022 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, 3, Authorised (updated)
27/09/2022 Withdrawn application: HemAryo, eptacog alfa (activated), Date of withdrawal: 06/05/2022, Initial authorisation (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Vaniqa, Eflornithine, Hirsutism, 19/03/2001, 23, Authorised (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Rybrevant, amivantamab, Carcinoma, Non-Small-Cell Lung, 09/12/2021, Additional monitoring, Conditional approval, 1, Authorised (updated)
26/09/2022 Union Pharmacovigilance Database: refresher webinar on signal management overview , Online, 10:00-12:00 Amsterdam time (CET), from 27/10/2022 to 27/10/2022
26/09/2022 Herbal medicinal product: Camelliae sinensis non fermentatum folium, Camelliae sinensis non fermentatum folium, F: Assessment finalised (updated)
26/09/2022 Other: List of signals discussed at PRAC since September 2012 (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 24, Authorised (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Atazanavir Mylan, atazanavir (as sulfate), HIV Infections, 22/08/2016, Generic, 12, Authorised (updated)
26/09/2022 Orphan designation: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene for the: Treatment of beta thalassaemia intermedia and major, 30/05/2016, Positive (updated)
26/09/2022 Agenda: Agenda of the PRAC meeting 26-29 September 2022
26/09/2022 Orphan designation: Ofranergene obadenovec for the: Treatment of ovarian cancer, 16/10/2017, Positive (updated)
26/09/2022 Orphan designation: Adenovirus-associated vector containing human Fas-c gene (ofranergene obadenovec) for the: Treatment of glioma, 06/06/2012, Positive (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, 19/12/2014, 11, Authorised (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 07/06/2010, Biosimilar, 25, Authorised (updated)
26/09/2022 Plasma master file certificates (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Colitis, Ulcerative, 13/08/1999, 61, Authorised (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic, 19/09/2019, Orphan, 11, Authorised (updated)
26/09/2022 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
26/09/2022 EPAR - Product Information: Soliris : EPAR - Product Information (updated)
26/09/2022 Human medicines European public assessment report (EPAR): Evusheld, tixagevimab, cilgavimab, COVID-19 virus infection, 25/03/2022, Additional monitoring, 1, Authorised (updated)
26/09/2022 Work programme: Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use (updated)
26/09/2022 Availability of medicines (updated)
26/09/2022 Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
26/09/2022 Other: Terms of reference of the HMA/EMA task force on availability of authorised medicines for human and veterinary use
23/09/2022 Human medicines European public assessment report (EPAR): Evkeeza, Evinacumab, Hypercholesterolemia, 17/06/2021, Additional monitoring, Exceptional circumstances, 1, Authorised (updated)
23/09/2022 Human medicines European public assessment report (EPAR): Kadcyla, trastuzumab emtansine, Breast Neoplasms, 15/11/2013, 14, Authorised (updated)
23/09/2022 Other: FAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 (updated)
23/09/2022 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
23/09/2022 Other: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated)
23/09/2022 Clinical Trials Information System: training and support (updated)
23/09/2022 News and press releases: New co-chairs elected for working parties for healthcare professionals and for patients and consumers
23/09/2022 Other: Clinical Trial Information System (CTIS) evaluation timelines
23/09/2022 Committee for Herbal Medicinal Products (HMPC): 18-20 July 2022 , from 18/07/2022 to 20/07/2022 (updated)
23/09/2022 Minutes: Minutes of the HMPC 18-20 July 2022 meeting
23/09/2022 Second Veterinary Big Data stakeholder forum , Online, 09:30 - 17:00 Amsterdam time (CET), from 23/11/2022 to 23/11/2022 (updated)
23/09/2022 Risk management information day 2022 , Virtual meeting, from 09/12/2022 to 09/12/2022
23/09/2022 Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection, 06/01/2021, Patient safety, Additional monitoring, Conditional approval, 29, Authorised (updated)
23/09/2022 Human medicines European public assessment report (EPAR): Rydapt, Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis, 18/09/2017, Orphan, 9, Authorised (updated)
23/09/2022 Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, 07/01/2021, Orphan, Additional monitoring, Exceptional circumstances, 5, Authorised (updated)
23/09/2022 Human medicines European public assessment report (EPAR): Nexpovio, Selinexor, Multiple Myeloma, 26/03/2021, Additional monitoring, 5, Authorised (updated)
23/09/2022 Direct healthcare professional communication (DHPC): Metalyse (tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution for injection: temporary supply shortage, Active substance: tenecteplase, DHPC type: Medicine shortage, Last updated: 23/09/2022
23/09/2022 Supply shortage: Shortage of Actilyse (alteplase) and Actilyse Cathflo (alteplase)
23/09/2022 Supply shortage: Shortage of Metalyse (tenecteplase)
23/09/2022 Human medicines European public assessment report (EPAR): Metalyse, tenecteplase, Myocardial Infarction, 23/02/2001, 21, Authorised (updated)
23/09/2022 Scientific and technical recommendations: Veterinary Medicines Regulation (updated)
23/09/2022 Regulatory and procedural guideline: Implementing measures under Article 93(2) of Regulation (EU) 2019/6 as regards the good manufacturing practice for veterinary medicinal products and active substances used as starting materials
23/09/2022 EudraVigilance training and support (updated)
23/09/2022 Human medicines European public assessment report (EPAR): Posaconazole Accord, posaconazole, Mycoses, 25/07/2019, Generic, 6, Authorised (updated)
23/09/2022 Other: Article 57 product data (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Libtayo, Cemiplimab, Carcinoma, Squamous Cell, 28/06/2019, Additional monitoring, Conditional approval, 12, Authorised (updated)
22/09/2022 Minutes: Minutes of the COMP meeting on 15-17 March 2022 (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Hulio, adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic, 17/09/2018, Additional monitoring, Biosimilar, 12, Authorised (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 23/11/2015, Orphan, Additional monitoring, 15, Authorised (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Ruxience, rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus, 01/04/2020, Additional monitoring, Biosimilar, 9, Authorised (updated)
22/09/2022 Orphan designation: Govorestat for the: Treatment of galactosaemia, 21/06/2022, Positive
22/09/2022 Orphan designation: Eltanexor for the: Treatment of myelodysplastic syndromes, 21/06/2022, Positive
22/09/2022 Orphan designation: Diflunisal for the: Treatment of ATTR amyloidosis, 21/06/2022, Positive
22/09/2022 Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase containing a polymorphism at position 671 for the: Treatment of methylmalonic acidaemia, 21/06/2022, Positive
22/09/2022 Orphan designation: 2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl -(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioadenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl for the: Treatment of cystic fibrosis, 21/06/2022, Positive
22/09/2022 Orphan designation: Human allogeneic keratinocytes for the: Treatment of partial deep dermal and full thickness burns, 21/06/2022, Positive
22/09/2022 Orphan designation: 2'-O-(2-methoxyethyl) modified antisense oligonucleotide targeting UBE3A antisense transcript RNA for the: Treatment of Angelman syndrome, 21/06/2022, Positive
22/09/2022 Orphan designation: Tamoxifen citrate for the: Treatment of neuronal ceroid lipofuscinosis, Positive
22/09/2022 Orphan designation: Sirolimus for the: Treatment of follicular lymphoma, 21/06/2022, Positive
22/09/2022 Orphan designation: Sirolimus for the: Treatment of lymphatic malformations, 21/06/2022, Positive
22/09/2022 Orphan designation: Lithium carbonate for the: treatment of TBR1-related disorder, 21/06/2022, Positive
22/09/2022 Human medicines European public assessment report (EPAR): Onglyza, Saxagliptin, Diabetes Mellitus, Type 2, 30/09/2009, 20, Authorised (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Komboglyze, metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2, 24/11/2011, 18, Authorised (updated)
22/09/2022 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
22/09/2022 Orphan designation: Humanised IgG4 monoclonal antibody against A proliferation-inducing ligand for the: Treatment of primary IgA nephropathy, 21/06/2022, Positive
22/09/2022 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 7, Authorised (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, 27, Authorised (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Arthritis, Rheumatoid, 16/12/2019, Additional monitoring, 12, Authorised (updated)
22/09/2022 Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Lymphoma, B-Cell, 16/01/2020, Orphan, Additional monitoring, 4, Authorised (updated)
21/09/2022 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, 7, Authorised (updated)
21/09/2022 Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 11, Authorised (updated)
21/09/2022 Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Asthma, 19/09/2022, Additional monitoring, Authorised
21/09/2022 Human medicines European public assessment report (EPAR): Illuzyce, lutetium (177Lu) chloride, Radionuclide Imaging, 15/09/2022, Authorised (updated)
21/09/2022 Human medicines European public assessment report (EPAR): Tabrecta, capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung, 20/06/2022, Additional monitoring, Authorised (updated)
21/09/2022 Organisation Management System (OMS) Trouble Shooting Session for CTIS users - July 2022 , Online, 14:00 - 15:00 Amsterdam time (CEST), from 21/07/2022 to 21/07/2022 (updated)
21/09/2022 IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry users , Online, 10:00 - 11:30 Amsterdam time (CEST), from 07/09/2022 to 07/09/2022 (updated)
21/09/2022 PRIME: priority medicines (updated)
21/09/2022 Report: List of products granted eligibility to PRIME (updated)
21/09/2022 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 September 2022
21/09/2022 Human medicines European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira), pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 19/11/2015, Generic, 14, Authorised (updated)
20/09/2022 Human medicines European public assessment report (EPAR): Lupkynis, Voclosporin, Lupus Nephritis, 15/09/2022, Additional monitoring, Authorised (updated)
20/09/2022 Human medicines European public assessment report (EPAR): Opdualag, nivolumab, Relatlimab, Melanoma, 15/09/2022, Additional monitoring, Authorised (updated)
20/09/2022 Human medicines European public assessment report (EPAR): Carmustine Obvius, carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin, 18/07/2018, Generic, 7, Authorised (updated)
20/09/2022 Human medicines European public assessment report (EPAR): Ontruzant, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 15/11/2017, Biosimilar, 14, Authorised (updated)
20/09/2022 Human medicines European public assessment report (EPAR): Replagal, agalsidase alfa, Fabry Disease, 03/08/2001, 28, Authorised (updated)
20/09/2022 Second Industry Standing Group (ISG) meeting , Online, from 26/09/2022 to 26/09/2022
20/09/2022 Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - September 2022 , Online, 14:00 - 18:00 Amsterdam time (CEST) , from 29/09/2022 to 30/09/2022 (updated)
20/09/2022 Human medicines European public assessment report (EPAR): Fortacin, lidocaine, prilocaine, Sexual Dysfunction, Physiological, 15/11/2013, 11, Authorised (updated)
20/09/2022 Other: Records of data processing activity of personal data in the context of public procurement procedures (public) (updated)
20/09/2022 Other: European Medicines Agency's Data Protection Notice for the processing of personal data in the context of public procurement procedures (updated)
20/09/2022 Agenda: Draft agenda - PCWP and HCPWP meeting - 22 September 2022 (updated)
20/09/2022 Scientific guideline: Concept paper on the establishment of a guideline on the development and manufacture of synthetic peptides
20/09/2022 Establishment of a guideline on the development and manufacture of synthetic peptides
20/09/2022 Scientific guideline: Concept paper on the establishment of a guideline on the development and manufacture of synthetic oligonucleotides
20/09/2022 Establishment of a guideline on the development and manufacture of synthetic oligonucleotides
20/09/2022 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Mylan, tenofovir disoproxil, HIV Infections, 08/12/2016, Generic, 16, Authorised (updated)
19/09/2022 Human medicines European public assessment report (EPAR): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts), Peanut Hypersensitivity, 17/12/2020, Additional monitoring, 5, Authorised (updated)
19/09/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022 (updated)
19/09/2022 Summary of opinion: Zynlonta , loncastuximab tesirine, 15/09/2022, Positive (updated)
19/09/2022 DADI PDF electronic application forms (eAF) training webinar , Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated)
19/09/2022 Human medicines European public assessment report (EPAR): Envarsus, tacrolimus, Graft Rejection, 18/07/2014, 11, Authorised (updated)
19/09/2022 News and press releases: Biosimilar medicines can be interchanged
19/09/2022 Agenda: Agenda - HMPC agenda of the 19-21 September 2022 meeting
19/09/2022 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 26/09/2017, 17, Authorised (updated)
19/09/2022 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis, 13/01/2016, Biosimilar, 16, Authorised (updated)
19/09/2022 Minutes: Minutes - PDCO minutes of the 22-25 March 2022 meeting (updated)
19/09/2022 Agenda: Agenda - PDCO agenda of the 19-22 April 2022 meeting (updated)
19/09/2022 Minutes: Minutes - PDCO minutes of the 22-25 February 2022 meeting (updated)
19/09/2022 Human medicines European public assessment report (EPAR): Nepexto, etanercept, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies; Spondylitis, Ankylosing; Psoriasis, 20/05/2020, Additional monitoring, Biosimilar, 7, Authorised (updated)
16/09/2022 Orphan designation: allogenic cytomegalovirus-specific cytotoxic T lymphocytes (adimlecleucel) for the: Treatment of cytomegalovirus infection in patients with impaired cell-mediated immunity, 18/11/2016, Withdrawn (updated)
16/09/2022 Scientific publications (updated)
16/09/2022 Orphan designation: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist (spanlecortemlocel) for the: Treatment of acute lymphoblastic leukaemia, 16/12/2014, Withdrawn (updated)
16/09/2022 Orphan designation: Autologous CD34+ cells transduced ex vivo with a lentiviral vector containing a modified gamma-globin gene for the: Treatment of sickle cell disease, 13/11/2020, Withdrawn (updated)
16/09/2022 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 29, Authorised (updated)
16/09/2022 Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022 , from 22/09/2022 to 22/09/2022 (updated)
16/09/2022 Other: Questions and answers on labelling flexibilities for COVID-19 vaccines (updated)
16/09/2022 Procurement (updated)
16/09/2022 Orphan designation: Self-complementary adeno-associated viral vector serotype 9 containing the SGSH gene for the: Treatment of mucopolysaccharidosis, type IIIA (Sanfilippo A syndrome), 20/09/2016, Positive (updated)
16/09/2022 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain; Cancer, 20/07/2009, 33, Authorised (updated)
16/09/2022 Summary of opinion: Enjaymo, sutimlimab, 15/09/2022, Positive
16/09/2022 Summary of opinion: Pyrukynd, mitapivat, 15/09/2022, Positive
16/09/2022 Summary of opinion: Melatonin Neurim, melatonin, 15/09/2022, Positive
16/09/2022 CHMP opinions on consultation procedures (updated)
16/09/2022 Other: Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (updated)
16/09/2022 Summary of opinion: Xalkori, crizotinib, 15/09/2022, Positive
16/09/2022 Summary of opinion: Adtralza, tralokinumab, 15/09/2022, Positive
16/09/2022 Summary of opinion: Exparel liposomal, bupivacaine, 15/09/2022, Positive
16/09/2022 Summary of opinion: Teriflunomide Accord, teriflunomide, 15/09/2022, Positive
16/09/2022 Summary of opinion: Livtencity, maribavir, 15/09/2022, Positive
16/09/2022 Summary of opinion: Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, 15/09/2022, Positive
16/09/2022 Summary of opinion: Revolade, eltrombopag, 15/09/2022, Positive
16/09/2022 Summary of opinion: Beyfortus, nirsevimab, 15/09/2022, Positive
16/09/2022 Summary of opinion: Teriparatide Sun, teriparatide, 15/09/2022, Positive
16/09/2022 Summary of opinion: Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), 15/09/2022, Positive
16/09/2022 Summary of opinion: Yescarta, axicabtagene ciloleucel, 15/09/2022, Positive
16/09/2022 News and press releases: New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection
16/09/2022 Summary of opinion: Skyrizi, risankizumab, 15/09/2022, Positive
16/09/2022 Summary of opinion: Mycapssa, octreotide, 15/09/2022, Positive
16/09/2022 Referral: Synchron , Article 31 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 19/05/2022, 16/09/2022 (updated)
16/09/2022 Summary of opinion: Sorafenib Accord , sorafenib, 15/09/2022, Positive
16/09/2022 Summary of opinion: Ximluci, ranibizumab, 15/09/2022, Positive
16/09/2022 Summary of opinion: Brukinsa, zanubrutinib, 15/09/2022, Positive
16/09/2022 Summary of opinion: Teriflunomide Mylan, teriflunomide, 15/09/2022, Positive
16/09/2022 Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, Accelerated assessment, 18, Authorised (updated)
16/09/2022 Other: Decision of the Management Board on amending budget No. 01, amending appropriations in budget 2022
16/09/2022 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:00 - 11:00 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated)
16/09/2022 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 15:00 - 16:00 Amsterdam time (CEST), from 25/07/2022 to 25/07/2022 (updated)
16/09/2022 News and press releases: EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
16/09/2022 Ad-hoc meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:30-12:30 Amsterdam time (CEST), from 07/07/2022 to 07/07/2022 (updated)
16/09/2022 Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward , Online, 13:30 - 17:30 Amsterdam time (CET), from 16/11/2022 to 16/11/2022 (updated)
16/09/2022 Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (updated)
16/09/2022 Antimicrobial-resistance surveillance as post-marketing authorisation commitment (updated)
16/09/2022 Scientific guideline: Concept paper on a guideline on data requirements for post-authorisation studies for antimicrobial veterinary medicinal products under Article 36(2) of Regulation (EU) 2019/6
16/09/2022 Minutes: Minutes of the CVMP meeting of 12-14 July 2022
16/09/2022 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 59, Authorised (updated)
15/09/2022 Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil phosphate, HIV Infections, 15/09/2016, Generic, 12, Authorised (updated)
15/09/2022 Human medicines European public assessment report (EPAR): Sialanar, glycopyrronium bromide, Sialorrhea, 15/09/2016, 9, Authorised (updated)
15/09/2022 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (updated)
15/09/2022 Regulatory and procedural guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel) (updated)
15/09/2022 Regulatory and procedural guideline: Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms (updated)
15/09/2022 Regulatory and procedural guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products (updated)